A few updates on the battle to get FDA to release the licensure documents for Pfizer’s vaccine, which will hopefully address most of the inquiries on this matter.
Aaron Siri 16th December
1. The FDA incredibly failed to send a representative to a federal court hearing in this matter on December 14th because of the “FDA’s protocols” regarding COVID-19. Meaning, despite the federal health agencies’ compliance rate with its mandatory vaccination policy of over 98.8% and its resounding claim that the vaccines are “effective,” the FDA is apparently still scared. Its actions speak volumes and cast serious doubt on its words.
2. Just prior to the Court hearing, the FDA released additional documents. These included a report on vaccine safety and a report on vaccine efficacy. There are many notable portions, but we will leave that to the scientists to analyze noting that, as the experts in the plaintiff’s group have explained, adequate analysis of the vaccines’ safety and efficacy is nearly impossible to complete without the full universe of documents.
3. Contrary to what has been reported elsewhere, there has been no decision issued in this case yet and any documents produced to date have been produced by the FDA apparently in the hopes of softening any decision the Court may render.
4. Regarding the hearing this week, the public will get to read the transcript when it is released, which we expect should be soon. In the meantime, it is noteworthy that the DOJ attorney who appeared without an FDA representative effectively argued that the American people and the plaintiff should just trust the FDA that it will produce documents as fast as possible even though it has now been over 110 days since the request was made to the FDA and it has produced on average only ~29 pages per day. The FDA also continued to maintain that it does not want the Court to require it to produce at a rate faster than 500 pages per month as it continued to harp on Pfizer’s interests and its trade secrets, for the most part ignoring the interests of the American people. For our part, we had the privilege of arguing many of the points that you can read below in our papers.
There is one point that is particularly noteworthy: Americans must routinely produce documents, pay fines, and otherwise expend resources to comply with the law. Courts don’t inquire as to the ability or financial resources to comply with the law – they must comply. In fact, it would be laughable if a billionaire defendant came before a court and claimed poverty to escape making a document production, but that is the FDA’s position. The Court, we hope, will do what it does with all parties: enter an order requiring the FDA to follow the law. If the FDA has an issue with doing so, it should take its complaint to Congress, not ask the Court to deviate from the law or give it any special accommodation from compliance with the laws that every other American must comply with.
(A more granular point for those interested: the FDA also argued that the Court cannot consider all of the evidence presented by the plaintiff in its papers because it is limited to consider only the record that was before the FDA when the agency initially denied the plaintiff’s request for expedited processing. The FDA must appreciate, however, that that rule only applies to deciding expedition – it does not apply to deciding the rate of production. The case law is clear on that point. Obviously, if that limitation did apply to the rate of production, none of the declarations submitted by the FDA could be considered by the Court. 266 F. Supp. 3d 241. In any event, even with regard to deciding expedition, numerous courts have held that they can rely on their equitable powers to consider documents outside the administrative record. 910 F. Supp. 2d 270, 274-75.)
5. As previously posted, the parties filed dueling opening briefs on December 6, 2021. On Monday, December 13, 2021, the parties filed dueling reply briefs. Below is a copy of the introduction from the December 13 brief responding to the FDA’s argument, and full copies of the parties’ December 13 papers are linked at the end of this article.
INTRODUCTION FROM PLAINTIFF’S REPLY BRIEF OF DECEMBER 13, 2021
Defendant, incredibly, focuses its opening brief on the idea that fairness requires it to take decades to produce the Pfizer vaccine licensure documents. Fairness? Fairness would be giving millions of Americans who are mandated to receive this liability-free vaccine today assurance regarding the FDA’s review by allowing independent scientists access to the same data the FDA reviewed, without making them wait decades. Fairness would be allowing Americans injured by the vaccine today, who cannot sue Pfizer or anyone else for the harm, hope that independent scientists with access to that data can more readily develop treatments for their ailments. Fairness would be our federal health authorities allocating more than one person spending a few hours each month to review Pfizer’s documents for public disclosure after having given Pfizer over $17 billion of taxpayer money to develop and market the product. Fairness would be releasing the documents so that independent scientists can have this data to assist in addressing serious issues of waning immunity, diminished efficacy, vaccine-immunity evading variants, etc. Fairness would be producing documents that the American taxpayers paid for while those same people are still alive, not decades after most are dead. That would be fair to the American people.